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The Needlestick Safety and Prevention Act (HR 5178):

What Does It Require?

By Gina Pugliese, R.N., M.S.

(Premier Safety Institute, Premier, Inc.)


Jane Perry, M.A.

(International Health Care Worker Safety Center, University of Virginia)

The Needlestick Safety and Prevention Act (H.R. 5178) mandated that the 1991 Bloodborne Pathogens Standard (29 CFR 1910.1030) be revised to strengthen the requirements related to the use of safety-engineered sharp devices. OSHA published the revised standard in the Federal Register on January 18, 2001; it became effective April 18, 2001. Below we review the major provisions of the law and discuss some frequently asked questions about it.

 Provisions of the new law:

n Requires health care employers to document in their exposure control plan that they have evaluated and implemented safety-engineered sharp devices and needleless systems in order to reduce employees' occupational exposure to HIV, hepatitis C and other bloodborne diseases; and

n Requires that exposure control plans be reviewed and updated at least annually to reflect changes in sharps safety technology.

n Requires each health care facility to maintain a sharps injury log with detailed information on percutaneous injuries (including type and brand of device involved in exposure incident, department where exposure occurred and an explanation of how it occurred).

n Requires employers to solicit input from non-managerial (e.g., frontline) health care workers when identifying, evaluating and selecting safety-engineered sharp devices, and to document this process in the exposure control plan.

n Expands the definition of "engineering controls" to include devices with engineered sharps injury protection.

Frequently Asked Questions:

nWhich health care facilities are covered by the new law?

The new federal law and the revised Bloodborne Pathogens Standard apply to any facility under federal OSHA where employees may be exposed to blood or other potentially infectious material, such as hospitals, long-term care facilities, clinical laboratories, physicians' offices and dentists. The law and revised standard do not cover public (state and municipal) facilities in federal OSHA states. (Note, however, that of the 27 states that are under federal OSHA, nine—Georgia, Maine, Massachusetts, Missouri, New Hampshire, Ohio, Rhode Island, Texas and West Virginia—have passed needle safety laws covering public health care settings.)

nWhat are the requirements for facilities in states with their own OSHA plans?

States with state OSHA plans (there are 23) must have regulations that are "at least as effective" (that is, at least as protective) as those of federal OSHA. These states must have a revised bloodborne pathogens standard that is equivalent to federal OSHA's in place by October 18, 2001. In the interim, state plans will continue to enforce their current requirements. Some states with state OSHA plans, such as California, have already revised their bloodborne pathogens standard to require the use of safer devices.

nWhat effect does the new law have on OSHA’s November 1999 compliance directive (CPL 202.44D) for the Bloodborne Pathogens Standard?

In drafting the federal Needlestick Safety and Prevention Act, legislators relied on the language and overall content of the compliance directive regarding requirements for the use of safety devices. H.R. 5178 provides legislative authority for OSHA’s current enforcement emphasis on the use of safety devices as a primary engineering control to prevent occupational exposures to bloodborne pathogens. In addition to emphasizing the use of safety devices, OSHA’s compliance directive also provides guidance on a number of other issues, such as updated requirements for post-exposure follow-up that include hepatitis C virus. (The revised compliance directive and additional compliance information and training resources are available on OSHA’s web site: www.osha-slc.gov/SLTC/needlestick/compliance.html.)

nDoes OSHA require safety devices now?

Use of sharps with engineered sharps injury protection is required now. OSHA has the authority under the Bloodborne Pathogens Standard to require the use of engineering controls, such as safety devices, to reduce risk to workers. OSHA clarified its position in November 1999 with the revised compliance directive, and outlined the requirements and enforcement procedures for implementation of sharps injury prevention devices. Since November 1999, OSHA has cited health care facilities for failure to use safety devices. In determining a facility’s compliance with the standard, OSHA has considered, among other factors, evidence of adoption of safety devices and whether the exposure control plan includes on-going selection, evaluation, and implementation of such devices, with a timeline for implementation.

The federal Needlestick Safety and Prevention Act does not change the current enforcement activities of OSHA, but rather gives a legislativemandate for OSHA’s requirement that health care employers provide their employees with safety-engineered sharp devices.

n Now that the Bloodborne Pathogens Standard has been revised to emphasize the use of safer devices, as mandated by H.R. 5178, will OSHA be stepping up its enforcement of the standard?

OSHA has already started conducting more inspections of health care facilities. During inspections, compliance with all occupational safety and health requirements is reviewed, including the Bloodborne Pathogens Standard. The increase in inspections is part of a recent initiative that included a letter sent to 2,600 health care facilities that had the highest average illness and injury rates, announcing that OSHA would be conducting targeted inspections. The major source for OSHA inspections of health care facilities, however, will still be employee complaints. Thus it will be important to adhere to the requirement in H.R. 5178 that frontline workers’ input be included in the development and implementation of a sharps injury program, in order to assure that their needs and safety concerns are being met.

nWhat should our facility do now?

  • Collect exposure data, using a system such as EPINet. This data is essential to understanding where exposures are occurring in a facility, and what interventions, including safer devices, are necessary to prevent them. If your facility already has a system in place for tracking sharp-object injuries and blood and body fluid exposures, make sure the forms solicit information on the following: type and brand of device causing the injury, department where the exposure occurred, and an explanation of how the incident occurred. The new federal law requires that this information be collected. (The latest Access version of EPINet includes all this information on its data collection forms; for a copy, call Ginger Parker at the International Health Care Worker Safety Center at (804) 982-0702, or e-mail her at gingerparker@virginia.edu.)
  • Establish a sharps injury task force. Each facility should have a multidisciplinary task force and assigned leader to coordinate the sharps injury prevention program. The task force should include both managerial and non-managerial (frontline) workers to assist with the development or revision of a plan for selection, evaluation and implementation of safety devices. Consider safety devices as one component of an overall sharps injury prevention program that includes management commitment to worker safety, education and training on the use of safety devices, strategies to encourage compliance with the use of safety devices, and ongoing evaluation of the effectiveness of safety devices in reducing the risk of injury from contaminated sharps.
  • Revise exposure control plan. The exposure control plan should be revised to include the plan and timetable for evaluating and implementing safety-engineered devices in all device categories with potential for bloodborne pathogen exposure. The involvement of frontline workers in the device selection process should be documented in the plan.
  • Select and evaluate devices. The new law does not recommend specific devices, but requires employers to conduct their own evaluations of available safety devices. At present, there are relatively few studies documenting the efficacy of specific safety devices. Therefore, hospitals must select devices to evaluate based on a consideration of their own needs and requirements. If your facility has group purchasing contracts, start by reviewing the safety devices that are currently under contract. Note, however, that health care facilities must evaluate any safety device they believe is appropriate for their specific needs, regardless of whether it is covered by a group purchasing contract.
  • Implement safety devices. When evaluation is complete, devices should be implemented promptly after appropriate education and training on the use of the device.

© 2000 Gina Pugliese and Jane Perry